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| Name | Class |
|---|---|
| Deutsche Krebshilfe e.V., Bonn (Germany) | OTHER |
| Arbeitsgemeinschaft Radiologische Onkologie | OTHER |
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The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.
The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.
To this end, 250 patients with histologically verified cancer of the cervix uteri of the stages IIB-IV shall be randomised to a standard arm (ARM B), whereby the therapy shall be conducted on the basis of the clinical FIGO stage.
The patients randomised to the test arm (Arm A), after determining the clinical FIGO stage, shall initially receive an operative staging in the form of a pelvine paraaortal lymphadenectomy (laparoscopic or open). On the basis of the operatively obtained findings, a ("surgically") modified tumour stage shall be determined. This "surgical" tumour stage, which shall take into account the affection of the lymph nodes, the infiltration of the neighbouring organs and the intraperitoneal spread, shall serve as the basis for the execution of primary, combined radio-chemotherapy. The primary end-point is the disease-free survival of both groups, the secondary endpoints are overall survival, the local control of both groups, as well as the determination of toxicity and the quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| operative staging (A) | Experimental | operative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open |
|
| Standard (B) | No Intervention | No surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--> CT controlled biopsy and histological analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lymphadenectomy | Procedure | paraaortal and pelvic lymphadenectomy laparoscopic or open |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS (disease-free survival) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity) | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone Marnitz, PD | Contact | 004930450627162 | simone.marnitz@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Simone Marnitz, PD | Department of Radiooncology (Charité Campus Mitte und Virchow), Charitéplatz 1, 10117 Berlin, Germany | Study Chair |
| Christhardt Köhler, Prof. | Department of Gynaecology (Charité Campus Mitte und Benjamin Franklin), Charitéplatz 1, 10117 Berlin, Germany |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin | Recruiting | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17566838 | Background | Sakuragi N. Up-to-date management of lymph node metastasis and the role of tailored lymphadenectomy in cervical cancer. Int J Clin Oncol. 2007 Jun;12(3):165-75. doi: 10.1007/s10147-007-0661-2. Epub 2007 Jun 27. | |
| 7784021 | Background | Subak LL, Hricak H, Powell CB, Azizi L, Stern JL. Cervical carcinoma: computed tomography and magnetic resonance imaging for preoperative staging. Obstet Gynecol. 1995 Jul;86(1):43-50. doi: 10.1016/0029-7844(95)00109-5. |
| Label | URL |
|---|---|
| Association for Radiooncology | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Standard Staging | Other | clinical Staging (FIGO) (examination in narcosis, biopsy, cystoscopy, rectoscopy) X-Ray Radiograph of Thorax, Ultrasound of abdomen, CT abdomen / pelvis positive, suspicious lymphnodes--> CT controlled biopsy |
|
|
| Study Chair |
| Anja Dittgen | Department of Gynaecology (Charité Campus Mitte), Charitéplatz 1, 10117 Berlin, Germany | Principal Investigator |
| Department of Radiooncology, Charité Campus Mitte und Campus Virchow | Recruiting | Berlin | 10117 | Germany |
|
| 17762920 | Background | Marnitz S, Kohler C, Roth C, Fuller J, Bischoff A, Wendt T, Schneider A, Budach V. Stage-adjusted chemoradiation in cervical cancer after transperitoneal laparoscopic staging. Strahlenther Onkol. 2007 Sep;183(9):473-8. doi: 10.1007/s00066-007-1675-4. |
| 10859007 | Background | Bye A, Trope C, Loge JH, Hjermstad M, Kaasa S. Health-related quality of life and occurrence of intestinal side effects after pelvic radiotherapy--evaluation of long-term effects of diagnosis and treatment. Acta Oncol. 2000;39(2):173-80. doi: 10.1080/028418600430734. |
| 10924990 | Background | Nag S, Erickson B, Thomadsen B, Orton C, Demanes JD, Petereit D. The American Brachytherapy Society recommendations for high-dose-rate brachytherapy for carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):201-11. doi: 10.1016/s0360-3016(00)00497-1. |
| 12694671 | Background | Lai CH, Huang KG, Hong JH, Lee CL, Chou HH, Chang TC, Hsueh S, Huang HJ, Ng KK, Tsai CS. Randomized trial of surgical staging (extraperitoneal or laparoscopic) versus clinical staging in locally advanced cervical cancer. Gynecol Oncol. 2003 Apr;89(1):160-7. doi: 10.1016/s0090-8258(03)00064-7. |
| 15721408 | Background | Denschlag D, Gabriel B, Mueller-Lantzsch C, Tempfer C, Henne K, Gitsch G, Hasenburg A. Evaluation of patients after extraperitoneal lymph node dissection for cervical cancer. Gynecol Oncol. 2005 Mar;96(3):658-64. doi: 10.1016/j.ygyno.2004.08.053. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |